MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI XI; SURGEON SIDE CONSOLE, RECONDITIONED

Model Number	380723-12
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported event.The fse replaced the generic cart controller (gcc) and generic power distributor (gpd) on the surgeon side console (ssc).The system was tested and verified as ready for use.Isi did receive the da vinci products involved with this complaint to perform failure analysis.The gcc was analyzed.Log review showed no data to indicate that the fault had occurred in the field.Visual inspection found the battery missing and a new one was installed.Then the gcc was installed onto an in-house system where the component functioned as expected.The golden system was set ergo calibration and 10 minutes sine cycle, 10 power cycles and sitting idle for 15 hours.Once the testing was completed, the system error logs were inspected but no error could be identified.The gpd was analyzed.Log review showed no data to indicate that the fault had occurred the field.Upon visual inspection, no issues were found related to the reported issue.The gpd was installed onto an in-house is4000 system where an error was triggered indicating fault on the gpd, replicating the reported event.The complaint was confirmed based on failure analysis.
Event or Problem Description
It was reported that prior to start of da vinci-assisted surgical procedure, site contacted intuitive technical support engineer (tse) to report the surgeon side console (ssc) was off and would not power on, despite the power breaker being set to on.A message indicated that the ssc was not connected to the system, although the vision side cart (vsc) and patient side cart (psc) were powered on.Surgeon had previously attempted to restart the system and reseat the blue fiber cables without success.The tse confirmed the ssc was not connected and guided site to try a different power socket and check the power cord for damage, which appeared fine.Despite leaving the ssc breaker off for a minute and turning it back on, the issue persisted.Surgeon could hear a fan running inside the ssc, but the touchpad remained black and the power button was not lit.The procedure was aborted with no patient involvement.

• Brand Name: DA VINCI XI
• Common Device Name: SURGEON SIDE CONSOLE, RECONDITIONED
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 24722660
• Report Number: 2955842-2026-19640
• Device Sequence Number: 18713451
• Product Code: NAY
• UDI-Device Identifier: 00886874115374
• UDI-Public: (01)00886874115374
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K131861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 380723-12
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Unknown